(79 days)
No
The summary describes a traditional resin-based tooth bonding system and does not mention any AI or ML components or functionalities.
No
The device is a bonding system used to secure restorative materials to tooth structure, which is a structural or supportive function rather than a therapeutic one (treating or alleviating a disease or condition).
No
The device is a bonding system for restorative materials, not a diagnostic tool. Its intended use is to bond materials to tooth structure, not to diagnose any condition.
No
The device description clearly states it is a "resin-based tooth bonding system" composed of an "etching gel and a primer/bond formulation," indicating it is a physical product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Bonding of enamel/dentin and composite or compomer restorative materials." This describes a process performed directly on the patient's tooth structure for restorative purposes.
- Device Description: The device is a "resin-based tooth bonding system" used to "bond composite and compomer restorative material to the tooth structure." This is a material used in a dental procedure.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body (like blood, urine, or tissue), or provide information for diagnostic purposes.
- Anatomical Site: The anatomical site is "tooth structure (dentin and enamel)," which is where the bonding material is applied directly.
IVD devices are typically used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Everbond® system is intended to bond composite and compomer restorative material to the tooth structure (dentin and enamel)
Product codes
KLE
Device Description
The Everbond® system is composed of an etching gel and a primer/bond formulation. The etching gel used in the Everbond® system is ESPE's 510(k) cleared MiniTip® Etching Gel (K810266).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth structure (dentin and enamel)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
To support substantial equivalence to Dentsply's predicate product Bond & Prime 2.1® the shear bond strength of the Everbond® system has been compared to that of Bond & Prime 2.1º by two institutes (J. Powers, University of Houston, Texas, USA and K .- H. Friedl, University of Regensburg, Germany).
To support substantial equivalence to ESPE's predicate products Pertac® II, Hytac® and Hytac® OSB the compositions have been compared.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.
0
DEC 1 6 1998
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS II.
ESPE is submitting a 510(k) premarket notification for its resin-based tooth bonding system, tradenamed Everbond®. The Everbond® system is intended to bond composite and compomer restorative material to the tooth structure (dentin and enamel), and is composed of an etching gel and a primer/bond formulation. The etching gel used in the Everbond® system is ESPE's 510(k) cleared MiniTip® Etching Gel (K810266). Concerning the intended use the priming/bonding agent is substantially equivalent to Dentsply's Multipurpose Dentin/Enamel Bonding Agent Bond & Prime 2.1® (K962348). Concerning the ingredients Everbond® is substantially equivalent to the formerly 510(k) cleared ESPE products Pertac® II (K962440), Hytac® (K962442), and Hytac® OSB (K962442). All predicate devices are well-established and determined to be safe, effective and beneficial.
To support substantial equivalence to Dentsply's predicate product Bond & Prime 2.1® the shear bond strength of the Everbond® system has been compared to that of Bond & Prime 2.1º by two institutes (J. Powers, University of Houston, Texas, USA and K .- H. Friedl, University of Regensburg, Germany).
To support substantial equivalence to ESPE's predicate products Pertac® II, Hytac® and Hytac® OSB the compositions have been compared.
ESPE's 510(k) has been submitted on September, 14, 1998 by Dr. Andreas Petermann at ESPE Platz, D-82229 Seefeld, Germany (011-49-8152-700395).
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Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines above it, possibly representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 6 1368
Dr. A. Petermann Requlatory Affairs ESPE Dental AG ESPE Platz D-82229 Seefeld/Oberbay GERMANY
Re : K983414 Everbond® Trade Name: Requlatory Class: II Product Code: KLE September 14, 1998 Dated: September 28, 1998 Received:
Dear Dr. Petermann:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
2
Page 2 - Dr. Petermann
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timothy A. Ulatows Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
STATEMENT OF INDICATIONS FOR USE lll.
| Device Name: | Everbond® (System) |
|---|---|
| - Everbond® (priming and bonding agent) | |
| - MiniTip® Etching Gel |
Indications for use:
Bonding of enamel/dentin and composite or compomer restorative materials.
Susan Renner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ Prescription Use _ (Per 21 CFR 801.109)